22 days old

Sample Management Consultant

Kelly Services
Warren, NJ 07059
**Title:** Sample Management Consultant

**Location:** Warren, NJ 07059

**Duration:** 12 months contract; possibly longer for the right candidates

**Compensation:** Up to $31.00 per hour; depending on experience


The Sample Management Consultant is responsible for the movement and control of QC samples and materials in support of the QC laboratories at the CAR T Development Operations facility in Warren, NJ. This includes, but is not limited to, sample collection and distribution, inventory control, chain of custody, sample tracking, sample pooling, sample aliquotting and sample delivery.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

Experience with cold chain sample storage and transfer.

Experience working in a GMP regulated environment.

Ability to work in a classified cleanroom environment and follow all applicable gowning requirements and procedures.

Ability to follow and apply global regulatory and GMP requirements.

Ability to follow, revise, and review SOPs.

Ability to work in a collaborative team environment.

Ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines.

Education and Experience:

Bachelors degree required, preferably in chemistry, microbiology, or related science.

2+ years of relevant work experience, preferably in a regulated environment.

An equivalent combination of education and experience may substitute.


Contributes to the management of test samples and reagents, including:

Responsible for sampling clinical QC incoming materials in collaboration with warehouse personnel.

Organizes shipment of samples to external laboratories, as applicable.

Supports on-site execution of the stability program samples per study protocol by ensuring stability samples are properly placed on stability time points with correct storage condition.

Initiates Deviation/CAPA and performs investigation in deviation, as applicable.

Create and revise SOP, FORM, WP, and TRN related to sample management.

Provide range of support of QC services such as ordering and receipt of lab supplies.

Establish and maintain Inventory of QC incoming material, QC Material retain, QC samples and QC Regulatory retains.

Develop understanding and assembly of weekly process schedule assignment for drug product samples and incoming QC materials.

Assist in analytical sample trouble shooting and investigations as needed.

Demonstrate general understanding of root cause analysis and CAPA methodologies.

Handling test samples throughout the sample lifecycle- receipt, storage, distribution, transfer, and disposal.

Maintaining sample tracking and chain of custody records in accordance with GMP requirements and written procedures.

Ensuring that obsolete or expired samples and materials are destroyed and disposed of according to written procedures.

Performing sample queries and periodic storage reports, as required.

Assisting management with investigations and deviations related to sample management and laboratory inventory.

Collaborating with other departments to identity and implement process efficiencies. Contributes to the management of laboratory inventory, including:

Maintaining the inventory of laboratory supplies including reagents, media, consumables, etc.

Maintaining the reference standard inventory and distributing reference standards to functional groups upon request.

Ensuring that materials are appropriately labelled and traceable according to GMPs, regulatory requirements, and written procedures.

Maintaining 5S and FIFO principles, as appropriate. Provides QC materials support, including:

Maintaining metrics for the sample management group.

Facilitating cold chain transfers of samples, as required.

Performs other tasks as assigned.

**Why Kelly** **** **?**

As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

**About Kelly** ****

At **Kelly** , were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

Posted: 2020-10-05 Expires: 2020-11-05

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Sample Management Consultant

Kelly Services
Warren, NJ 07059

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